Plain English Summary
Background and study aims
A national survey carried out by the French Society of Anesthesia and Critical Care with INSERM showed that 15% of anesthetic acts in France were due to diagnostic procedures. Several authors have raised this issue because of the cost involved at national level. For invasive diagnostic radiology (angiography), the necessity of the presence of an anesthesiologist is highly controversial. The safety aspect is mentioned but it is questionable because accidents are rare (approximately 0.1%) in those procedures. This explains that, in many centres, an anesthesiologist can be reached in case of an incident but is not present during the whole procedure. Another justification is to improve patient comfort and satisfaction. Some patients do not want to be sedated because of the possibility of post interventional drowsiness and legal constraints related to the anesthetic action (visit 48 hours in advance, monitoring for several hours etc). This uncertainty about the desired level of sedation is reflected in a wide range of anesthesia practices, ranging from simple monitoring to deep sedation for arteriography.
Controlled sedation the patient (also called PCS) is a method derived from patient-controlled analgesia or PCA. The advantage of this technique is to control the patient's level of sedation. This study assesses how well the PCS method works.
Who can participate?
Participants aged under 70 years, with ASA physical status below 3, a scheduled cerebral angiography, and a consultation with an anesthetist at least 48 hours before the procedure.
What does the study involve?
61 patients were randomly allocated to one of two groups: receiving propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).
What are the possible benefits and risks of participating?
Possible benefits were an improve experience of the sedation and fast recovery. Potential risks were insufficient sedation or secondary effects of propofol.
Where is the study run from?
France, Public Hospital of Marseille, neuroradiology operating room.
When is the study starting and how long is it expected to run for?
The study started in January 2000 and was expected to last 6 months.
Who is funding the study?
There was institutional funding from AP-HM, Public Hospital of Marseille, Research Department.
Who is the main contact?
Dr Axel Maurice-Szamburski
axel.maurice@ap-hm.fr
Trial website
Contact information
Type
Scientific
Primary contact
Dr Axel Maurice-Szamburski
ORCID ID
Contact details
264 rue St. Pierre
Marseille
13009
France
axel.maurice@ap-hm.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
00/15
Study information
Scientific title
Effect of patient-controlled sedation with propofol on patient satisfaction: a randomised study
Acronym
Study hypothesis
The aim of this study was to evaluate the difference in patient satisfaction, assessed by a specific and validated scale, using a propofol-based PCS compared to placebo-based PCS for diagnostic cerebral angiography.
Ethics approval
Ethical approval n°:00/15, Chairperson Pr. J-C Manelli, Ethical Committee: CPP Sud-Méditerranée II - Hôpital Salvator, Marseille, France.
Study design
Prospective double blinded randomised
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diagnostic cerebral angiography
Intervention
We randomly assigned 61 patients to receive propofol-based PCS (n = 33, 15 mg bolus in 9 s) or placebo-based PCS (n = 28, bolus of 1.5 mL of a 20% lipid emulsion in 9 s).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The main objective was to evaluate whether a propofol-based PCS would lead at least to 20% difference in patients satisfaction on the EVAN scale, which was self reported the day after the procedure.
Secondary outcome measures
Secondary objectives were to assess the quality of patient conditioning by the neuroradiologist and the anesthetist and to report possible side effect.
Overall trial start date
01/01/2000
Overall trial end date
01/07/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age under 70 years
2. ASA physical status below 3
3. Scheduled cerebral angiography
4. Consultation with an anesthetist at least 48 hours before the procedure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Age under 18 years,
2. Emergency context
3. History of psychiatric disease
4, Long-course anxiolytic treatment
5. Counter-indication to propofol
6. Withdrawal of consent
Recruitment start date
01/01/2000
Recruitment end date
01/07/2000
Locations
Countries of recruitment
France
Trial participating centre
264 rue St. Pierre
Marseille
13009
France
Sponsor information
Organisation
Assistance Publique Hôpitaux de Marseille AP-HM (France)
Sponsor details
264 rue St.Pierre
Marseille
13005
France
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Institutional funding from AP-HM, Public Hospital of Marseille, Research Department.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. Auquier, P. et al. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology 102, 11161123 (2005).
2. Maurice-Szamburski, A., Bruder, N., Loundou, A., Capdevila, X. & Auquier, P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology 118, 7887 (2013).